FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Bioprocessing Trends To Watch In 2018
    Bioprocessing Trends To Watch In 2018

    Although it has remained relatively insulated from broader worldwide economic trends, the biopharmaceutical industry continues to focus on improved bioprocessing technologies to reduce costs and increase efficiencies. Targeting improvements in production can not only lower operational costs, it also can improve weak development pipelines, especially in developing economies.

  • How To Engage Regulators To Reduce Biopharma Manufacturing Timelines
    How To Engage Regulators To Reduce Biopharma Manufacturing Timelines

    Part 1 of this two-part Q&A explored the ways in which the FDA encourages innovation, the role of the agency’s Emerging Technology Team (ETT) in manufacturing innovation, and the innovation-safety balance for rare or orphan disease treatments. In this installment, the experts discuss whether compounding pharmacies can help enable iterative development, the feasibility of just-in-time drug manufacturing, and recommendations for speeding materials release.

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PHARMA OUTSOURCING WHITE PAPERS

Insights And Tips When Addressing Bioburden Challenges Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

Over-Encapsulation: Common Questions And Challenges
White Paper: Over-Encapsulation: Common Questions And Challenges
Manufacturing Spray-Dried Dispersions: Process Control Strategies

This paper broadly describes a model-based SDD product development methodology as well as a control strategy that is based upon fundamental understanding of the formulation and the process.

For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research

“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.

Crystalomics: A Pathway Forward For Protein Crystallization

One way to lower the suspension viscosity of a drug is through the use of highly-concentrated crystalline suspensions, or protein crystals.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Are You Into Biosimilars?

Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.

From Concept To Reality: Fujifilm Forges A Path To Future Growth With SUT

In 2009, Fujifilm Diosynth Biotechnologies (Fujifilm), a biologics CDMO for over 20 years, sought to expand its cell culture operations to meet the industry’s need for more manufacturing capacity. Fujifilm began to look at single-use technology (SUT), and questioned if it offered the same performance as stainless steel when it came to cell growth, cellular productivity, and product quality? By learning the answer to this question and others about SUT, Fujifilm was able to use its knowledge as early adopters, expand its business capabilities, and, as a result, look forward to new growth well into the future.

Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System

This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

Innovation With Single-Use: Merck Calls For Collaboration To Overcome Challenges

As the industry — and Merck — sees its pipelines expanding into these more targeted areas of treatment, the call for flexibility and speed gets even louder. Many feel an answer to this is single-use technology (SUT). At Merck, there has been a continued momentum of sales in biologics and vaccines over the last 15 years. However, we had not fully explored SUT or its full potential implementation in our facilities. That is, until an outside industry expert gave us the brutally honest assessment that we were “behind” when it came to SUT.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template December 18, 2017
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Renovating Pharmaceutical Manufacturing Facilities for Aseptic Fill/Finish: Critical Planning, Execution & Compliance Tips January 10, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Introductory Rate
Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
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